Syringe piston with check valve seal

ABSTRACT

A fluid syringe of the type used with fluid infusion devices is presented here. The fluid syringe generally includes a barrel, a piston, and a check valve seal. The barrel has an interior wall and a sealed main fluid chamber. The piston is slidably coupled within the barrel, and the piston has a piston seal forming an interference fluid seal against the interior wall. The check valve seal is coupled to the piston, and it is located between the piston seal and the main fluid chamber. The check valve seal forms an interference fluid seal against the interior wall when the piston is unloaded, and it disengages the interior wall to allow gas flow from the main fluid chamber toward the piston seal when the piston is loaded.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/972,263, filed Dec. 17, 2010, which claims the benefit of U.S.provisional patent application No. 61/289,243, filed Dec. 22, 2009 (nowexpired).

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally tosyringes and syringe pistons of the type used to deliver fluids, such asmedication. More particularly, embodiments of the subject matter relateto a syringe piston having a check valve seal.

BACKGROUND

Portable medical devices are useful for patients that have conditionsthat must be monitored on a continuous or frequent basis. For example,diabetics are usually required to modify and monitor their dailylifestyle to keep their body in balance, in particular, their bloodglucose (BG) levels. Individuals with Type 1 diabetes and someindividuals with Type 2 diabetes use insulin to control their BG levels.To do so, diabetics routinely keep strict schedules, including ingestingtimely nutritious meals, partaking in exercise, monitoring BG levelsdaily, and adjusting and administering insulin dosages accordingly.

The prior art includes a number of fluid infusion devices and insulinpump systems that are designed to deliver accurate and measured doses ofinsulin via infusion sets (an infusion set delivers the insulin througha small diameter tube that terminates at, e.g., a cannula inserted underthe patient's skin). In lieu of a traditional syringe, the patient cansimply activate the insulin pump to administer an insulin bolus asneeded, for example, in response to the patient's current BG level.

A typical infusion pump includes a housing, which encloses a pump drivesystem, a fluid containment assembly, an electronics system, and a powersupply. The pump drive system typically includes a small motor (DC,stepper, solenoid, or other varieties) and drive train components suchas gears, screws, and levers that convert rotational motor motion to atranslational displacement of a piston in a reservoir, which may be inthe form of a user-filled syringe or a pre-filled syringe. The fluidcontainment assembly typically includes the reservoir with the piston,tubing, and a catheter or infusion set to create a fluid path forcarrying medication from the reservoir to the body of a user. Theelectronics system regulates power from the power supply to the motor.The electronics system may include programmable controls to operate themotor continuously or at periodic intervals to obtain a closelycontrolled and accurate delivery of the medication over an extendedperiod.

The presence of air bubbles in a fluid syringe is undesirable forvarious reasons. Accordingly, air inside of user-filled syringes isusually expelled before the syringe is used. Moreover, air might beintroduced into a pre-filled syringe during the filling and sealingprocesses. Therefore, various manufacturing techniques are implementedin an attempt to remove air from pre-filled syringes before sealingand/or to minimize the amount of air that gets introduced into thefluid. In this regard, conventional approaches often rely on vacuumfilling and/or vacuum stoppering to remove or reduce the amount of airthat gets trapped in the pre-filled syringes. Such techniques, however,involve specialized equipment, require additional handling of theproduct, and result in lower throughput.

Accordingly, it is desirable to have a different methodology forhandling gas trapped inside of a fluid syringe. In addition, it isdesirable to have a syringe piston design and a related syringe pistonthat can be manipulated to manage the presence of gas inside of thefluid chamber.

BRIEF SUMMARY

An exemplary embodiment of a syringe piston is provided. The syringepiston includes a piston body having a fluid end and an actuator endopposite the fluid end, and a piston seal coupled to the piston body andlocated between the fluid end and the actuator end. The piston sealforms an interference fluid seal with an interior wall of a syringebarrel. The syringe piston also includes a check valve seal coupled tothe piston body and positioned such that the piston seal is locatedbetween the check valve seal and the actuator end, and a gas entrapmentzone defined between the check valve seal and the piston seal. The checkvalve seal allows one-way gas flow into the gas entrapment zone.

Also provided is an exemplary embodiment of a fluid syringe. The fluidsyringe includes a syringe barrel comprising an interior wall and asealed main fluid chamber, a syringe piston slidably coupled within thesyringe barrel, and a check valve seal coupled to the syringe piston andlocated between the piston seal and the main fluid chamber. The syringepiston includes a piston seal forming an interference fluid seal againstthe interior wall. The check valve seal forms an interference fluid sealagainst the interior wall when the syringe piston is unloaded, and thecheck valve seal disengages the interior wall to allow gas flow from themain fluid chamber toward the piston seal when the syringe piston isloaded.

An exemplary embodiment of a method of manufacturing a fluid syringe isalso provided. The method involves the fabrication of a syringe assemblyhaving a syringe barrel having an interior wall and a main fluidchamber, a sealing cap having a penetrable membrane, a syringe pistonslidably coupled within the syringe barrel and partially defining themain fluid chamber, and a liquid within the main fluid chamber. Thesyringe piston includes a piston seal forming an interference fluid sealagainst the interior wall, and a check valve seal located between thepiston seal and the main fluid chamber. The method continues bymaintaining the syringe assembly in a position that allows gas in themain fluid chamber to accumulate and rise toward the syringe piston and,after the gas in the main fluid chamber has settled at the check valveseal, applying a force to the syringe piston to move the syringe pistoninto the syringe barrel while maintaining the syringe assembly in theposition. The check valve seal allows the gas to flow from the mainfluid chamber into an entrapment zone defined between the piston seal,the check valve seal, and the interior wall. After the gas flows pastthe check valve seal into the entrapment zone, the method removes theforce from the syringe piston to return the check valve seal to anunbiased state, such that the check valve seal retains the gas in theentrapment zone.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures.

FIG. 1 is a schematic representation of an embodiment of a fluidinfusion device;

FIG. 2 is an exploded perspective view of the fluid infusion deviceshown in FIG. 1;

FIG. 3 is a cross-sectional view of the fluid infusion device (as viewedalong line 3-3 in FIG. 2) with a fluid syringe installed therein;

FIG. 4 is a cross-sectional view of an exemplary embodiment of a fluidsyringe, taken along its major longitudinal axis;

FIG. 5 is a side view of an exemplary embodiment of a syringe pistonthat is suitable for use with the fluid syringe shown in FIG. 3; and

FIGS. 6-10 are diagrams that illustrate a fluid syringe and a method ofmanufacturing it.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Certain terminology may be used in the following description for thepurpose of reference only, and thus are not intended to be limiting. Forexample, terms such as “upper”, “lower”, “above”, and “below” refer todirections in the drawings to which reference is made. Terms such as“front”, “back”, “rear”, “side”, “outboard,” and “inboard” describe theorientation and/or location of portions of the component within aconsistent but arbitrary frame of reference which is made clear byreference to the text and the associated drawings describing thecomponent under discussion. Such terminology may include the wordsspecifically mentioned above, derivatives thereof, and words of similarimport. Similarly, the terms “first”, “second” and other such numericalterms referring to structures do not imply a sequence or order unlessclearly indicated by the context.

The subject matter presented here relates to a check valve seal for apiston that is used to deliver a fluid (such as a liquid medication)from a fluid syringe to a person. Although the check valve seal conceptcan be utilized with user-filled syringes or pre-filled syringes,certain benefits described herein apply to pre-filled syringes that donot easily accommodate the expulsion of trapped air by the user.Accordingly, the following description focuses on pre-filled syringeembodiments. Moreover, the following description relates to a fluidinfusion device of the type used to treat a medical condition of apatient. The infusion device is used for infusing fluid into the body ofa user. The non-limiting examples described below relate to a medicaldevice used to treat diabetes (more specifically, an insulin pump),although embodiments of the disclosed subject matter are not so limited.Accordingly, the infused fluid is insulin in certain embodiments. Inalternative embodiments, however, many other fluids may be administeredthrough infusion such as, but not limited to, disease treatments, drugsto treat pulmonary hypertension, iron chelation drugs, pain medications,anti-cancer treatments, medications, vitamins, hormones, or the like.For or the sake of brevity, conventional features and characteristicsrelated to infusion system operation, insulin pump and/or infusion setoperation, fluid reservoirs, and fluid syringes may not be described indetail here. Examples of infusion pumps and/or related pump drivesystems used to administer insulin and other medications may be of thetype described in, but not limited to, United States patent applicationnumber 2009/0299290 A1 (the content of which is incorporated byreference in its entirety herein).

The check valve seal and the syringe assembly described here facilitatethe containment of entrapped air, which may be introduced or createdduring the syringe filling process of a pre-filled syringe (after pistonseating in the syringe barrel). Some conventional syringe pistonsinclude two seals designed to protect the syringe-filled solutions fromenvironmental conditions. A syringe with the two-seal design mightcontain solution and air within the syringe after piston installation.Air entrapped in the syringe is only vented by inverting the syringe andexpelling a small quantity of solution/air mixture prior to needleinjection.

In contrast to conventional syringe designs, the syringe pistondescribed here includes an additional seal (the check valve seal) thatfaces the fluid chamber. The check valve seal is constructed to serve asa mechanical check valve between the syringe solution and the otherpiston seals. When positioned upright (i.e., the piston end of thesyringe up), the entrapped air in the syringe will rise to the pistonbase. Thereafter, the piston is engaged (moved toward the solution inthe fluid chamber) while the tip of the syringe is sealed. This mode ofpiston engagement allows entrapped solution/air to pass by the checkvalve seal into a cavity of the syringe, thereby containing the air andkeeping the air out of the syringe solution. The check valve is designedto eliminate backflow of the solution/air mixture from the containmentcavity to the syringe solution. Thus, when the syringe is capped orsealed, the check valve seal can be manipulated like a flap toaccommodate fluid flow in one direction while inhibiting fluid flow inthe other direction.

Referring now to the drawings, FIG. 1 is a schematic representation ofan embodiment of a fluid infusion device 100, and FIG. 2 is an explodedperspective view of the fluid infusion device 100. FIG. 1 also shows aninfusion set 102 coupled to the fluid infusion device 100. The fluidinfusion device 100 is designed to be carried or worn by the patient.The fluid infusion device 100 may leverage a number of conventionalfeatures, components, elements, and characteristics of conventional andwell known fluid infusion devices. For example, the fluid infusiondevice 100 may incorporate some of the features, components, elements,and/or characteristics described in U.S. Pat. Nos. 6,485,465 and7,621,893, the relevant content of which is incorporated by referenceherein.

Referring to FIG. 1, the fluid infusion device 100 includes a userinterface 104 that includes several buttons that can be activated by theuser. These buttons can be used to administer a bolus of insulin, tochange therapy settings, to change user preferences, to select displayfeatures, and the like. Although not required, the illustratedembodiment of the fluid infusion device 100 includes a display element106. The display element 106 can be used to present various types ofinformation or data to the user, such as, without limitation: thecurrent glucose level of the patient; the time; a graph or chart of thepatient's glucose level versus time; device status indicators; etc. Insome embodiments, the display element 106 is realized as a touch screendisplay element and, therefore, the display element 106 also serves as auser interface component.

The fluid infusion device 100 accommodates a fluid syringe 107 (see FIG.2) for the fluid to be delivered to the user. Note that the words“syringe” and “reservoir” are used interchangeably herein; both refer toa fluid containment component that can be actuated to dispense fluid. Alength of tubing 108 fluidly couples the fluid syringe 107 to theinfusion set 102. The tubing 108 extends from the fluid infusion device100 to the infusion set 102, which provides fluid communication with thebody of the user. A removable cap or fitting 110 is suitably sized andconfigured to accommodate replacement of fluid reservoirs (which aretypically disposable) as needed. In this regard, the fitting 110 isdesigned to accommodate the fluid path from the fluid syringe 107 to thetubing 108.

FIG. 3 is a cross-sectional view of the fluid infusion device 100 withthe fluid syringe 107 installed therein. The illustrated embodiment ofthe fluid infusion device 100 includes, without limitation: a housing120; an electronics assembly 122; a slide 124; and a drive system 126.The housing 120 includes an opening adapted to receive the fluid syringe107. FIG. 3 illustrates the relationship between the drive system 126,the slide 124, and the fluid syringe 107. FIG. 3 shows other componentsand features that are conventional in nature and/or are unrelated to thesubject matter presented here. Moreover, it should be appreciated thatFIG. 3 depicts the fluid infusion device 100 in a simplified manner. Inpractice, the fluid infusion device 100 could include additionalelements, features, or components that are not shown or described indetail here.

The housing 120 has a hollow interior that accommodates the electronicsassembly 122, the fluid syringe 107, the slide 124, and the drive system126, which are enclosed within the housing 120 by a bottom portion 128.In the illustrated embodiment, the slide 124, the drive system 126, andthe fluid syringe 107 are aligned in an axial direction (indicated byarrow 130). As described in greater detail below, the drive system 126facilitates displacement of the slide 124 in the axial direction 130 todispense fluid from the fluid syringe 107.

The electronics assembly 122 includes control electronics that generallyrepresent the hardware, firmware, processing logic and/or software (orcombinations thereof) to control operation of the drive system 126 andother features of the fluid infusion device 100. In an exemplaryembodiment, the electronics assembly 122 includes one or moreprogrammable controllers that may be programmed to control the variousoperations of the fluid infusion device 100.

Depending on the embodiment, the fluid syringe 107 may be realized as adisposable reservoir, a user-filled reservoir, a pre-filled reservoir, avial, a cartridge, or the like. In certain embodiments, the infusedfluid is insulin, although many other fluids may be administered throughinfusion such as, but not limited to, HIV drugs, drugs to treatpulmonary hypertension, iron chelation drugs, pain medications,anti-cancer treatments, medications, vitamins, hormones, or the like.The fluid syringe 107 typically includes a barrel 140 that contains thefluid and is concentrically and/or coaxially aligned with the slide 124(e.g., in the axial direction 130) when the fluid syringe 107 isinstalled in the fluid infusion device 100. The fluid delivery end ofthe fluid syringe 107 may include a suitably configured sealing cap 142that cooperates with the fitting 110 in a way that allows the fitting110 to secure the fluid syringe 107 in the housing 120. When the fitting110 is in place (as depicted in FIG. 3), displacement of the fluidsyringe 107 in the axial direction 130 is inhibited. In an exemplaryembodiment, the sealing cap 142 includes a penetrable membrane that ispunctured by a delivery needle 144 of the fitting 110. In this manner,the fitting 110 secures the fluid syringe 107 within the housing 120 andalso serves to secure and connect the fluid syringe 107 to the infusionset tubing 108.

The base end of the fluid syringe 107 (which is near the slide 124)includes a syringe piston 150 positioned to push fluid from inside thebarrel 140 of the fluid syringe 107 along a fluid path through thetubing 108 to a user. Note that the words “piston,” “stopper,” and“plunger” may be used interchangeably herein; these words all refer tothe component that moves within the fluid syringe 107 to dispense fluidfrom the barrel 140. The slide 124 is configured to mechanically coupleor otherwise engage with the piston 150, thereby becoming seated withthe piston 150. In operation, fluid is forced from the fluid syringe 107via the tubing 108 as the drive system 126 is actuated to displace theslide 124 in the axial direction 130 toward the sealing cap 142.

In an exemplary embodiment, the drive system 126 includes a motorassembly 154 and a drive screw 156. The motor assembly 154 might includea motor and associated drive train components that convert rotationalmotor motion to a translational displacement of the slide 124 in theaxial direction 130, thereby engaging and displacing the piston 150 ofthe fluid syringe 107. In some embodiments, the motor assembly 154 mayalso be powered to rewind the slide 124 in the opposing direction toaccommodate removal and replacement of the fluid syringe 107. Althoughthe illustrated embodiment of the fluid infusion device 100 utilizes acoaxially aligned drive system 126, the motor assembly 154 could insteadbe arranged in an offset or otherwise non-coaxial manner, relative tothe longitudinal axis of the fluid syringe 107.

The drive screw 156 mates with internal threads 158 internal to theslide 124. When the motor assembly 154 is powered, the drive screw 156rotates, and the slide 124 is forced to translate in the axial direction130. In an exemplary embodiment, the fluid infusion device 100 includesa feature that prevents the slide 124 from rotating when the drive screw156 rotates. Thus, rotation of the drive screw 156 causes the slide 124to extend or retract relative to the motor assembly 154. When the fluidinfusion device 100 is assembled and operational, the slide 124 contactsthe piston 150 to engage the fluid syringe 107 and to control deliveryof fluid from the fluid infusion device 100. In an exemplary embodiment,a shoulder portion 160 of the slide 124 contacts or otherwise engagesthe piston 150 to displace the piston 150 in the axial direction 130. Inalternative embodiments (not shown), the slide 124 may include athreaded tip capable of being detachably engaged with internal threadsformed in the piston 150, as described in detail in U.S. Pat. Nos.6,248,093 and 6,485,465, which are incorporated by reference herein.

FIG. 4 is a cross sectional view of an exemplary embodiment of a fluidsyringe 200, taken along its major longitudinal axis. Note that thefluid syringe 200 could be used as one suitable embodiment of the fluidsyringe 107 shown in FIG. 2 and FIG. 3. This particular embodiment ofthe fluid syringe 200 is a pre-filled component, and FIG. 4 depicts thefluid syringe 200 in its pre-filled state prior to use and prior toinstallation into a fluid infusion device. The fluid syringe 200generally includes, without limitation: a body or barrel 202; a piston204; a sealing cap 206; and fluid 208 contained in the barrel 202. Forthis example, the fluid 208 is a liquid medication such as insulin.

The barrel 202 can be formed from plastic, metal, glass, or the like.The barrel 202 has a base end 212 and a cap end 214 opposite the baseend 212. The base end 212 may include or cooperate with a retainingfeature 216 that is designed to retain the piston 204 within the barrel202. The retaining feature 216 prevents the piston 204 from slipping outof the barrel 202 during manufacturing, shipping, storage, and handlingof the fluid syringe 200. The retaining feature 216 could be realized asan inward protruding rim or shoulder (as depicted in FIG. 4), as one ormore keyway features, as a separate ring or other securing componentthat can be coupled to the fluid syringe 200, or the like. The cap end214 of the barrel 202 has a generally conical-shaped portion 220 whichtapers to a neck region 222. The sealing cap 206 is installed onto theneck region 222, thereby forming a fluid-tight seal. In accordance withconventional reservoir designs, the sealing cap 206 includes apenetrable membrane 224 or an insert that can be pierced by a dispensingneedle (as described above with reference to FIG. 3). The penetrablemembrane 224 may also be referred to as a “septum.” The penetrablemembrane 224 is designed to preserve its seal after it is pierced, tominimize leakage of fluid around the dispensing needle.

The barrel 202 has an interior wall 226 that defines a main fluidchamber 228 of the barrel 202. As shown in FIG. 4, the fluid 208 resideswithin the main fluid chamber 228. The main fluid chamber 228 is sealedafter the fluid syringe 200 is filled with the fluid 208; FIG. 4 depictsthe main fluid chamber 228 in its sealed state. The end surface 230 ofthe piston 204 also defines the main fluid chamber 228, which changesvolume as the piston 204 is moved within the barrel 202.

The piston 204 is slidably coupled within the barrel 202, such thatactuation of the piston 204 results in the delivery of the fluid 208(when the main fluid chamber 228 is unsealed, for example, by piercingthe membrane 224). The piston 204 is suitably designed to form afluid-tight barrier within the barrel 202 such that the fluid 208 doesnot leak from the base end 212 of the fluid syringe 200 and such thatcontaminants do not enter the main fluid chamber 228. This particularembodiment of the piston 204 includes, without limitation: a piston body240; a check valve seal 242; a piston seal 244; and an end seal 246. Theend seal 246 may be realized as a second piston seal, or, in certainembodiments, the piston seal 244 and the end seal 246 may be one and thesame. In yet other embodiments, three or more seals could be used withthe check valve seal 242.

The piston body 240 can be formed from plastic, metal, glass, or thelike. The piston body 240 has a fluid end 250 and an actuator end 252opposite the fluid end 250. When the piston 204 is installed in thebarrel 202, the fluid end 250 is near the main fluid chamber 228. Thepiston body 240 has a cavity 254 defined therein. The cavity 254 isshaped and sized to receive an actuation component, such as the tip ofthe slide 124 shown in FIG. 3. The exterior of the piston body 240includes a number of features that accommodate the check valve seal 242,the piston seal 244, and/or the end seal 246. In this regard, theexterior of the piston body 240 may include one or more of the followingfeatures or elements (formed therein, attached thereto, or coupledthereto), without limitation: ridges; shoulders; flanges; protrusions;cavities; rims; slots; holes; seats; grooves; and contours. For theembodiment illustrated in FIG. 4, the piston body 240 includes onecircumferential groove that accommodates and retains the end seal 246and another circumferential groove that accommodates and retains thepiston seal 244. The piston body 240 may also include another groove orother feature for the check valve seal 242. The illustrated embodiment,however, includes a check valve seal 242 that is mounted atop the pistonbody 240 such that the major outer surface of the check valve seal 242faces the fluid 208. Depending on its design, the check valve seal 242could be coupled to the piston body 240 by way of a press-fit orsnap-fit engagement.

The end seal 246 is coupled to the piston body 240 near the actuator end252, the check valve seal 242 is coupled to the piston body 240 near thefluid end 250, and the piston seal 244 is coupled to the piston body 240at a location between the fluid end 250 and the actuator end 252. Morespecifically, the piston seal 244 is positioned between the check valveseal 242 and the end seal 246, as shown in FIG. 4. The piston seal 244is formed from a suitable material or composition that enables thepiston seal 244 to form an interference fluid seal with the interiorwall 226 of the barrel 202. In this regard, the piston seal 244 ispreferably formed from a resilient and pliable material such as rubber,plastic, urethane, or the like. In certain embodiments, the piston seal244 is realized as a rubber o-ring that is coupled around the pistonbody 240. The end seal 246 may be configured as described above for thepiston seal 244 and, indeed, the end seal 246 is identical to the pistonseal 244 in some embodiments.

When the piston 204 is installed in the barrel 202, the check valve seal242 forms an interference fluid seal against the interior wall 226 whenthe piston 204 is unloaded (i.e., no force is applied to the piston204). FIG. 4 depicts the check valve seal 242 in this nominal state. Incertain embodiments, the check valve seal 242 includes a flap 260 thatforms the interference fluid seal with the interior wall 226. Asexplained below, the flap 260 is intentionally designed with asymmetricdeflection characteristics. More specifically, the flap 260 is shaped,sized, and otherwise configured such that it is easier to deflect in thedirection toward the actuator end 252, and such that it is difficult todeflect in the direction away from the actuator end 252. In other words,the flap 260 functions as a one-way fluid flow regulator. For thisembodiment, the check valve seal 242 is tapered such that it is thinnerat its outer perimeter (near the barrel 202). In this regard, the checkvalve seal 242 may resemble an arrowhead.

In practice, the check valve seal 242 is preferably formed from aresilient and pliable material such as rubber, plastic, urethane, or thelike. In certain embodiments, the check valve seal 242 is formed from amaterial or composition that is different than that used for the pistonseal 244 and the end seal 246. In this regard, the piston seal 244 andthe end seal 246 may be formed from a resilient material having a firstdurometer, and the check valve seal 242 may be formed from a differentresilient material having a second durometer (e.g., the second durometeris higher than the first durometer). Alternatively, the durometer of thepiston seal 244 may be equal to the durometer of the check valve seal242. Consequently, the static, dynamic, and structural properties of thematerial used for the check valve seal 242 might be different than thestatic, dynamic, and structural properties of the material used for thepiston seal 244 and the end seal 246.

FIG. 5 is a side view of an exemplary embodiment of a syringe piston 300that is suitable for use with the fluid syringe 200. Many of thefeatures and characteristics of the piston 300 are identical or similarto that described above for the piston 204. Accordingly, common featuresand aspects of the pistons 204, 300 will not be described in detailhere. This embodiment of the piston 300 generally includes, withoutlimitation: a piston body 302; a check valve seal 304; a piston seal306; and an end seal 308. As described above for the piston 204, thepiston seal 306 and the end seal 308 fit within respective groovesformed in the exterior of the piston body 302. Piston 300 also employs athird groove for the check valve seal 304. Thus, the check valve seal304 may be realized as a ring-shaped seal that is stretched or otherwisemanipulated for installation into its retaining groove. In this regard,the fluid end 310 of the piston body 302 is located above the checkvalve seal 304. This particular embodiment of the check valve seal 304exhibits a sloped and angled profile, such that its perimeter is verythin at the point of contact with the barrel 202. Notably, the surfaceof the check valve seal 304 that faces the main fluid chamber slopesdownward toward the barrel 202 and toward the end seal 308, as shown inFIG. 5. Of course, the shape, size, and profile of the check valve seal304 could vary from that shown here.

The pistons 204, 300 are suitably configured with various fluid, gas,and/or buffer zones or chambers defined between the different seals. Asbest shown in FIG. 5, the piston 300 includes a fluid entrapment zone320 defined between the check valve seal 304, the piston seal 306, andthe interior wall 321 of the barrel 202. In typical implementations, thefluid entrapment zone 320 is utilized as a collection and retentionchamber for unwanted air or other gas that might be present afterfilling the fluid syringe. As described in more detail below, undercertain conditions the check valve seal 304 allows one-way fluid flowinto the fluid entrapment zone 320 when the syringe piston 300 isinstalled in the barrel 202. In this regard, when the fluid syringe isdeployed and unsealed for purposes of dispensing fluid, the check valveseal 304 forms an interference fluid seal against the interior wall 321of the barrel 202 and inhibits or prevents fluid flow from the fluidentrapment zone 320 into the main fluid chamber within the barrel 202.

The piston 300 may also include a buffer zone 322 or chamber definedbetween the piston seal 306, the end seal 308, and the interior wall 321of the barrel 202. The buffer zone 322 is helpful to inhibit or preventthe incursion of outside contaminants or moisture into the main fluidchamber within the barrel 202. In certain embodiments, the piston seal306 inhibits or prevents fluid flow from the fluid entrapment zone 320toward the end seal 308. In other words, the piston seal 306 inhibits orprevents fluid flow from the fluid entrapment zone 320 into the bufferzone 322.

The check valve seals 242, 304 described here facilitate the handling ofair or other gas that might become trapped in a pre-filled fluid syringeduring manufacturing. In this regard, FIGS. 6-10 are diagrams thatillustrate an exemplary embodiment of a fluid syringe and an exemplarymethod of manufacturing it. FIG. 6 depicts a syringe assembly 400 as itis being filled with a liquid 401. The syringe assembly 400 includes abarrel 402, a piston 404, and a check valve seal 406 having the featuresand characteristics described above. The piston 404 is depicted in asimplified schematic form in FIGS. 6-10 for the sake of clarity.

As shown in FIG. 6, the main fluid chamber 408 is filled by dispensingthe liquid 401 into the neck region 410 of the barrel 402, which is openor uncapped. In practice, the piston 404 is positioned at or near thebottom of the barrel 402 during the filling operation. This position(shown in FIG. 6) may be considered to be the filling position of thepiston 404. The check valve seal 406 cooperates with and seals againstthe interior wall of the barrel 402 while the liquid 401 is dispensedinto the barrel 402. Consequently, the liquid 401 remains above thecheck valve seal 406 and it does not leak into the fluid containmentzone 412. The liquid 401 is dispensed into the neck region 410 until thebarrel 402 is filled. Thereafter, the manufacturing process may installa sealing cap 414 onto the neck region 410 to seal the liquid 401 insidethe barrel 402 (see FIG. 7). At this time, the barrel 402 and the mainfluid chamber are closed (sealed) and the piston 404 is unloaded and inan uncompressed state. Under these conditions the check valve seal 406maintains the seal against the interior wall of the barrel 402, as shownin FIG. 7.

Air or other gas might be introduced into the liquid during the fillingprocess. Moreover, some of this gas can be trapped inside the barrel 402after securing the sealing cap 414 in place. In this regard, FIG. 7schematically depicts gas bubbles 418 dispersed throughout the liquid401 inside the barrel 402. The manufacturing process may continue byinverting the syringe assembly 400 and maintaining it in a position thatallows gas in the main fluid chamber to accumulate and rise toward thepiston 404 (see FIG. 8). In practice, the syringe assembly 400 should beheld in an upright (vertical) position with the check valve seal 406above the sealing cap 414, to allow the gas bubbles 418 in the liquid401 to rise, accumulate, and settle at or near the check valve seal 406.The wavy arrows in FIG. 8 represent the rising and settling of the gasnear the check valve seal 406. Depending upon the specific manufacturingprocedure, the syringe assembly 400 may be held in the settling positionwithout applying any additional stimuli. Alternatively, it may bedesirable to accelerate the settling of the gas (if possible) by gentlyagitating the syringe assembly 400, by changing the surroundingtemperature, or the like.

After the gas in the barrel 402 has settled at the check valve seal 406,an actuation force is applied to the piston 404 (while maintaining thesyringe assembly 400 in its inverted position). The arrows 424 in FIG. 9represent the actuation force. The actuation force 424 causes the piston404 to slightly move into the barrel 402 toward the sealing cap 414, asdepicted in FIG. 9. The compression of the piston 404 at this timecauses the check valve seal 406 to temporarily disengage from theinterior wall of the barrel, as shown in the detail section of FIG. 9.Note that disengagement of the check valve seal 406 in this manneroccurs because the barrel 402 and the main fluid chamber are sealed andthe piston is loaded under a compressive force. Under these conditions,the check valve seal 406 allows the gas to flow from the main fluidchamber into the fluid entrapment zone 412. The arrow 426 in the detailsection of FIG. 9 indicates the flow path of the gas past the checkvalve seal 406. The piston 404 can be moved into the barrel 402 as faras needed to entrap the desired amount of gas within the fluidentrapment zone 412.

After the desired amount of gas flows past the check valve seal 406 andinto the fluid entrapment zone 412, the actuation force 424 is removedfrom the piston 404 to return the check valve seal 406 to its nominaland unbiased state. FIG. 10 depicts the syringe assembly after removalof the actuation force 424. In this state the check valve seal 406retains the captured gas 430 in the fluid entrapment zone 412. At thistime, manufacturing of the syringe assembly 400 can be completed asdesired. The check valve seal 406 is suitably configured to maintain thecaptured gas 430 in the fluid entrapment zone 412 while fabrication ofthe syringe assembly 400 is completed, during packaging, shipping, andstorage of the syringe assembly 400, and during user manipulation andinstallation of the syringe assembly 400. In this regard, the capturedgas 430 should remain in the fluid entrapment zone 412 after the syringeassembly 400 is installed in a fluid infusion device (see FIG. 3).Moreover, the captured gas 430 remains in the fluid entrapment zone 412after the syringe assembly 400 has been opened (unsealed) for purposesof dispensing fluid. In particular, the check valve seal 406 maintainsits seal against the interior wall of the barrel 402 when the main fluidchamber is unsealed (e.g., the sealing cap 414 has been penetrated), andwhen the piston is compressed for purposes of delivering the liquid outof the barrel 402.

Accordingly, the check valve seals described above can be utilized witha piston of a fluid reservoir such that the reservoir can be pre-filledin an easy and cost efficient manner without performing time consumingand complicated procedures intended to completely eliminate the presenceof gas or air during filling. Rather, the check valve seals allow amanufacturer of pre-filled reservoirs to tolerate and accommodate someamount of gas that might be trapped inside the sealed reservoirs. Thecheck valve seals, along with the manufacturing procedure describedabove, can be used to collect and capture the trapped gas without havingto perform a post-fill venting or priming operation.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. Rather, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application.

What is claimed is:
 1. A syringe piston comprising: a piston body havinga fluid end and an actuator end opposite the fluid end; a piston sealcoupled to the piston body and located between the fluid end and theactuator end, wherein the piston seal forms an interference fluid sealwith an interior wall of a syringe barrel; a check valve seal coupled tothe piston body and positioned such that the piston seal is locatedbetween the check valve seal and the actuator end; and a gas entrapmentzone defined between the check valve seal and the piston seal, whereinthe check valve seal allows one-way gas flow into the gas entrapmentzone.
 2. The syringe piston of claim 1, wherein the check valve sealcomprises a flap that forms an interference fluid seal with the interiorwall of the syringe barrel under nominal operating conditions.
 3. Thesyringe piston of claim 1, wherein the check valve seal inhibits gasflow from the gas entrapment zone into the syringe barrel.
 4. Thesyringe piston of claim 1, further comprising an end seal coupled aroundthe piston body and positioned such that the piston seal is locatedbetween the check valve seal and the end seal.
 5. The syringe piston ofclaim 4, wherein the piston seal inhibits gas flow from the gasentrapment zone toward the end seal.
 6. The syringe piston of claim 4,further comprising a buffer zone defined between the piston seal and theend seal.
 7. The syringe piston of claim 1, wherein: the piston seal isformed from a first resilient material having a first durometer; and thecheck valve seal is formed from a second resilient material having asecond durometer that is different than the first durometer.
 8. Thesyringe piston of claim 1, wherein: the check valve seal comprises aflap that cooperates with the interior wall of the syringe barrel; theflap seals against the interior wall of the syringe barrel when thesyringe barrel is closed and the syringe piston is uncompressed; theflap disengages the interior wall of the syringe barrel when the syringebarrel is closed and the syringe piston is compressed; and the flapseals against the interior wall of the syringe barrel when the syringebarrel is open and the syringe piston is compressed for purposes ofdispensing fluid.
 9. A syringe piston comprising: a piston body having afluid end and an actuator end opposite the fluid end; a piston sealcoupled to the piston body and located between the fluid end and theactuator end, wherein the piston seal forms an interference fluid sealwith an interior wall of a syringe barrel; a check valve seal coupled tothe piston body and positioned such that the piston seal is locatedbetween the check valve seal and the actuator end, the check valve sealcomprising a flap having asymmetric deflection characteristics such thatthe flap is easier to deflect in a direction toward the actuator end,relative to deflection in a direction away from the actuator end; and agas entrapment zone defined between the check valve seal and the pistonseal, wherein the check valve seal allows one-way gas flow into the gasentrapment zone.
 10. The syringe piston of claim 9, wherein the flapfunctions as a one-way fluid flow regulator.
 11. The syringe piston ofclaim 9, wherein the flap forms an interference fluid seal with theinterior wall of the syringe barrel under nominal operating conditions.12. The syringe piston of claim 9, wherein the check valve seal inhibitsgas flow from the gas entrapment zone into the syringe barrel.
 13. Thesyringe piston of claim 9, further comprising an end seal coupled aroundthe piston body and positioned such that the piston seal is locatedbetween the check valve seal and the end seal.
 14. The syringe piston ofclaim 9, wherein: the piston seal is formed from a first resilientmaterial having a first durometer; and the check valve seal is formedfrom a second resilient material having a second durometer that isdifferent than the first durometer.
 15. The syringe piston of claim 9,wherein: the flap cooperates with the interior wall of the syringebarrel; the flap seals against the interior wall of the syringe barrelwhen the syringe barrel is closed and the syringe piston isuncompressed; the flap disengages the interior wall of the syringebarrel when the syringe barrel is closed and the syringe piston iscompressed; and the flap seals against the interior wall of the syringebarrel when the syringe barrel is open and the syringe piston iscompressed for purposes of dispensing fluid.
 16. A syringe pistoncomprising: a piston body having a fluid end and an actuator endopposite the fluid end; a piston seal coupled to the piston body andlocated between the fluid end and the actuator end, wherein the pistonseal forms an interference fluid seal with an interior wall of a syringebarrel; a check valve seal coupled to the piston body and positionedsuch that the piston seal is located between the check valve seal andthe actuator end, the check valve seal comprising a flap that cooperateswith the interior wall of the syringe barrel; and a gas entrapment zonedefined between the check valve seal and the piston seal, wherein thecheck valve seal allows one-way gas flow into the gas entrapment zone,and inhibits gas flow from the gas entrapment zone into the syringebarrel; wherein the flap seals against the interior wall of the syringebarrel when the syringe barrel is closed and the syringe piston isuncompressed; the flap disengages the interior wall of the syringebarrel when the syringe barrel is closed and the syringe piston iscompressed; and the flap seals against the interior wall of the syringebarrel when the syringe barrel is open and the syringe piston iscompressed for purposes of dispensing fluid.
 17. The syringe piston ofclaim 16, further comprising an end seal coupled around the piston bodyand positioned such that the piston seal is located between the checkvalve seal and the end seal.
 18. The syringe piston of claim 17, whereinthe piston seal inhibits gas flow from the gas entrapment zone towardthe end seal.
 19. The syringe piston of claim 17, further comprising abuffer zone defined between the piston seal and the end seal.
 20. Thesyringe piston of claim 16, wherein: the piston seal is formed from afirst resilient material having a first durometer; and the check valveseal is formed from a second resilient material having a seconddurometer that is different than the first durometer.